Senior Manager, QA Microbiology of Drug Substance
- Regeneron Pharmaceuticals, Inc.
- Rensselaer, New York
- Start date
- Mar 27, 2023
- Quality, Science/R&D, Microbiology, Pharmacology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Pharm Country, Best Places to Work
The Senior Manager, QA Microbiology of Drug Substance is responsible for being the primary QA lead for microbial/aseptic awareness training and ambassador of Rensselaer based personnel as it relates to microbial controls and aseptic practices. The position includes defining individual departmental training strategies as they relate to each department’s role in biopharmaceutical production and standardization of microbial training activities through coordination with all sites of Regeneron Industrial Operations and Product Supply (IOPS).
As a Senior Manager of QA Microbiology a typical day might include the following:
- Tackles the coaching role in relation to training activities.
- Builds microbial and aseptic training scenarios and presentations including, but not limited to, hands-on simulated production scenarios, presentations regarding process steps, job expectations and regulatory requirements and general information intended to expedite development of personnel.
- Presents training to newly hired employees to facilitate their participation in cGMP production activities and facilitates cross-training opportunities for existing Regeneron Employees.
- Observes microbial and aseptic practices in the classified areas and provides feedback to area management.
- Analyzes trend data as it relates to Microbial recoveries.
- Participates in multidisciplinary project teams to coordinate and establish training goals.
- Aids' investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plans determination, product impact and remediation plans.
- Maintains industry standards with respect to microbial control/ mitigation; aims to supervise and incorporate any new industry standards.
- Stays up-to-date on developments in standard processes relating to relevant technology, contamination/environmental controls, etc.
- Reviews and provides input on SOPs, microbiology assay validation, sterilization and related documentation.
- Reviews and provides input on environmental monitoring SOPs executions.
- Manages direct reports in all aspects of QA Microbiology and metric analysis.
- Other responsibilities include supporting microbial investigations, supporting regulatory audits, supporting the Raheen IOPS site and reviewing and approving microbial related deviations.
- Ability to travel approximately 25% of the time, both domestic and international.
This role may be for you if you have:
- Knowledge of current industry microbial aseptic practices required.
- Ability to enter and work in aseptic controlled environments is required.
- Device and filling experience preferred but not required.
- Basic knowledge of Biopharmaceuticals and cell culture manufacturing required.
To be considered for this role you must hold a Bachelors Degree in Microbiology or Life Science field and
- Associate Manager: 6 years relevant experience in the pharmaceutical/biotechnology or related industry with at least 2 years in a leadership role
- Manager: 7 years relevant experience in the pharmaceutical/biotechnology or related industry with at least 2 years in a leadership role
- Senior Manager: 8 years relevant experience in the pharmaceutical/biotechnology or related industry with at least 2 years in a leadership role
- Master’s degree in Microbiology preferred. Relevant experience may be considered in lieu of the educational requirement.
#REGNQA #LI-HybridDoes this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)$85,800.00 - $180,500.00
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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